Biovian to make AAVs for ANLBIO Alzheimer’s gene therapy candidate

CDMO Biovian Oy says it has the capacity to support viral vector needs through trials and beyond for ANLBIO from its Turku, Finland facilities.

The deal sees biotech ANLBIO contract Biovian to support upcoming trials of its Alzheimer’s disease gene therapy candidate ANL-101.

Financials have not been disclosed, but the Finnish contract development and manufacturing organization (CDMO) will supply GMP Cell Bank manufacturing, process and analytical development, and validation of product-specific analytical methods from its site in Turku.

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“This is a substantial deal for Biovian considering the plans with global clinical trial entry and potential commercialization,” Biovian’s CEO Antti Nieminen told BioProcess Insider. “We have the capacity to support ANLBIO many years ahead.”

Biovian is licensed for GMP production of both investigational drugs and commercial gene therapy products, and, if ANL-101 moves through the clinic, the CDMO will upscale the process to work volume of hundreds of liters and carry out drug product manufacture under the deal.

“Biovian has about two-decade-long history in process development and manufacturing of viral vectors,” Nieminen said. “As a one-stop-shop CDMO we also provide ANLBIO development of product-specific analytical methods and aseptic filling as part of the contract.”

ANLBIO said it selected Biovian after reviewing numerous other CDMOs.

“ANLBIO has reviewed for half a year a lot of candidates who can produce, with the lowest risk and in a co-development manner, drug substance and drug product of ANL101,” the South Korean firm told.

“For the reason that the therapeutic modality of ANL101 belongs to AAV gene therapy, we have scrutinized AAV records of certain CDMOs on the list. A lot of AAV records of the company and the team of dedicated professionals, in particular, helped us choose Biovian as our partner and we expect that we must be able to prepare a clinical drug for ANL101 most acceptably with Biovian.”